CSV Engineer

PSC Biotech® Corporation; Chicago (IL); On-site; USD 90,000 - 150,000; Full time

Job summary

PSC Biotech® Corporation in the United States is seeking Computer System Validation (CSV) Engineers of varying experience levels to support validation and compliance activities for computerized systems used within regulated life sciences environments. This role covers a wide range of platforms including laboratory, manufacturing, automation, quality, and enterprise applications.

You will author and review validation plans, URS, FS, risk assessments, traceability matrices, test scripts, summary

Qualifications

• Bachelor's degree in Computer Science, Information Systems, Engineering, Life Sciences, Biotechnology, Chemistry, or a related discipline.
• Experience supporting computerized system validation activities within regulated pharmaceutical, biotechnology, medical device, or related industries.
• Understanding of GxP regulations, data integrity requirements, and computerized system compliance principles.
• Experience authoring CSV lifecycle documentation and executing validation testing.
• Familiarity with risk-based validation methodologies and Computer Software Assurance (CSA) concepts.
• Knowledge of electronic records and electronic signature requirements.
• Strong technical writing and documentation skills.
• Excellent analytical, troubleshooting, and problem-solving capabilities.
• Strong communication and stakeholder management skills.
• Ability to travel to client sites as required.
• Must be authorized to work in the U.S.
• No C2C at this time.

Responsibilities

• Develop and execute CSV documentation in line with regulatory requirements and procedures.
• Author and review validation plans, URS, FS, risk assessments, traces, test scripts, reports, and SOPs.
• Support implementation and validation of computerized systems through the lifecycle.
• Execute IQ/OQ/PQ/UAT and document testing activities.
• Conduct risk assessments using risk-based validation and CSA concepts.
• Evaluate systems for data integrity and e-record requirements.
• Support change control, deviations, CAPA, and periodic reviews.
• Collaborate with QA, IT, Automation, Engineering, Manufacturing, and Lab Ops.
• Participate in system implementations, upgrades, migrations, and enhancements.
• Maintain validated-state through lifecycle activities.
• Support regulatory inspections, audits, and client reviews.
• Travel to client sites as required.

Skills

GxP knowledge

CSV lifecycle docs

Technical writing

Validation testing

Risk-based validation

CSA concepts

Electronic records & signatures

Stakeholder management

Travel readiness

US work authorized

Education

Bachelor's degree in CS/IS/Engineering/Life Sciences

Job description

PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.

The Experience

With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you decide join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.

We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.

At PSC Biotech®, it’s about more than just a job—it’s about your career and your future.

Your Role

We are seeking Computer System Validation (CSV) Engineers of varying experience levels to support validation and compliance activities for computerized systems used within regulated life sciences environments. The CSV Engineer will be responsible for ensuring computerized systems are implemented, maintained, and operated in compliance with regulatory expectations, data integrity requirements, and client quality standards.

This position supports a wide range of platforms including laboratory systems, manufacturing systems, automation platforms, quality systems, and enterprise applications.

• Develop and execute Computer System Validation documentation in accordance with regulatory requirements and company procedures.
• Author and review validation plans, user requirements specifications, functional specifications, risk assessments, traceability matrices, test scripts, summary reports, and SOPs.
• Support implementation and validation of computerized systems throughout the system lifecycle.
• Execute and document system testing activities including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and User Acceptance Testing (UAT).
• Conduct risk assessments utilizing risk-based validation and CSA methodologies.
• Evaluate computerized systems for compliance with data integrity and electronic records requirements.
• Support change control, deviation investigations, CAPA activities, and periodic system reviews.
• Collaborate with Quality Assurance, IT, Automation, Engineering, Manufacturing, and Laboratory Operations teams.
• Participate in software implementation projects, upgrades, migrations, and system enhancements.
• Ensure validated-state maintenance through lifecycle management activities.
• Support regulatory inspections, audits, and client reviews.
• Maintain project documentation and ensure compliance with client and industry standards.
• Travel to client sites as required to support system implementation and validation efforts.

Requirements

• Bachelor's degree in Computer Science, Information Systems, Engineering, Life Sciences, Biotechnology, Chemistry, or a related discipline.
• Experience supporting computerized system validation activities within regulated pharmaceutical, biotechnology, medical device, or related industries.
• Understanding of GxP regulations, data integrity requirements, and computerized system compliance principles.
• Experience authoring CSV lifecycle documentation and executing validation testing.
• Familiarity with risk-based validation methodologies and Computer Software Assurance (CSA) concepts.
• Knowledge of electronic records and electronic signature requirements.
• Strong technical writing and documentation skills.
• Excellent analytical, troubleshooting, and problem-solving capabilities.
• Strong communication and stakeholder management skills.
• Ability to manage multiple projects and priorities simultaneously.
• Ability and willingness to travel as required by client projects.
• Must be authorized to work in the U.S.
• No C2C at this time.

Benefits

Equal Opportunity Employment Statement

PSC is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.